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Gastric Procedures for Obesity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01026181
First Posted: December 4, 2009
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
Shahzeer Karmali, University of Alberta
  Purpose
This is a prospective case series study; all morbidly obese patients that need surgical management in Royal Alexandra Hospital will be provided 3 surgical options: Laparoscopic Sleeve Gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LR-en-Y), and laparoscopic gastric banding (LGB), safety and effectiveness will be compared among the 3 groups. The outcome measures will be percentage of excess weight loss, BMI, operative time, hospital stays, complications and improvement of comorbidities.

Condition
Morbid Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase II Study of Comparing Outcomes of Laparoscopic Sleeve Gastrectomy, Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Gastric Banding to Treat Morbid Obesity

Further study details as provided by Shahzeer Karmali, University of Alberta:

Primary Outcome Measures:
  • Change in Body Weight [ Time Frame: baseline to 2-year postoperation ]
    Change of body weight in Kilograms measured at follow-up visits two year after surgery

  • Change in BMI [ Time Frame: from baseline to 2-year postoperation ]

    Patients' weight and height were measured at follow up visit 2 years post operation.

    BMI was calculated using the formula: weight (kg)/height(meter)^2



Enrollment: 150
Study Start Date: September 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
LSG
Laparoscopic Sleeve Gastrectomy
LRYGB
Laparoscopic Roux-en-Y Gastric Bypass
LAGB
Laparoscopic Adjustable Gastric Banding

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Morbidly obese patients aged from 18 to 65.
Criteria

Inclusion Criteria:

  • morbid obese patients aged from 18-65,
  • BMI > 40 kg/m2 or BMI> 35 kg/m2 with severe comorbidities: diabetes, sleep apnea, hypertension etc.

Exclusion Criteria:

  • psychiatric illness,
  • substance abuse,
  • previous gastrointestinal surgery, and
  • any patient who transfers from laparoscopic to convention procedure.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Shahzeer Karmali, BSc, MD, FRCSC, University of Alberta
ClinicalTrials.gov Identifier: NCT01026181     History of Changes
Other Study ID Numbers: Pro00002425
First Submitted: December 3, 2009
First Posted: December 4, 2009
Results First Submitted: December 8, 2016
Results First Posted: October 3, 2017
Last Update Posted: October 3, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms